India’s Drug Export NOC Reform and New Pharma Regulation
Why in the news
India simplified export clearance for unapproved drugs and announced new guidelines for advanced therapies, along with tighter oversight and a digital tracking platform.
Old vs new NOC system
| Aspect | Earlier | Now |
|---|---|---|
| Basis | Application for every order, by customer and quantity | Blanket NOC from one year of export history |
| Scope | Importer-wise | Product and country specific, not tied to one importer |
| Volume | About 15,000 a year | About 5,000 a year |
| Paperwork | Repeated | Customer details and regulatory proof once a year |
Key facts
- Biosimilars: new guidelines replace the 2018 version and align with global norms.
- Cell and gene therapy: India’s first regulatory framework by CDSCO, DBT and ICMR.
- Inspections: 905 in two years; scrutiny increased after the Aveo case.
- Digital regulatory platform: ₹100 crore, to map the supply chain from approval to sale; ready in about two years.
Growth and concerns
- Pharma exports rose 9%, nearly twice the global pace (McKinsey).
- Risks: shifting regulations in India and abroad, and stricter scrutiny in low and middle income countries (LMICs).
Exam angle
- Agencies: CDSCO, DBT, ICMR.
- Platform cost: ₹100 crore.
- Key reform: blanket, product- and country-specific NOC.